Panel Says 3 Allergy Drugs Should Be Sold Over the Counter

By MILT FREUDENHEIM

Published: May 12, 2001

A proposal to make the three most popular and expensive allergy drugs available without a prescription won strong support yesterday from a government medical advisory panel.

The panel voted overwhelmingly to advise the Food and Drug Administration that Claritin, Allegra and Zyrtec were just as safe as many nonprescription allergy medications that have long been sold in drugstores and supermarkets.

The decision was a setback for the makers of the drugs, which advertise heavily and sell millions of pills for a total of $5 billion a year. It was a victory for the health insurance industry, which passes on a large portion of the cost to consumers and employers in insurance premiums and out-of-pocket payments.

Surging use of effective but costly new drugs has been a primary cause of the double-digit rise in health care costs.

Industry executives said they would pursue the fight over allergy drugs inside the Bush administration, which has not yet appointed a commissioner of the F.D.A. They said the issue was also likely to come up in Senate hearings when the president does appoint a commissioner.

''We are disappointed, but we are sure this is not a done deal,'' said Dr. François Nader, a senior vice president of Aventis S.A., which makes Allegra. ''The next step is for the F.D.A. to look at all the reservations and comments presented by the panel'' and witnesses.

Dr. Robert Seidman, chief pharmacy officer of Wellpoint Health Networks, which brought the issue to the F.D.A., said the recommendations were ''history making.''

But Schering-Plough said in a statement that the panel's 19-to-4 vote on Claritin, its top-selling allergy drug, was ''a nonbinding recommendation.'' The vote margin was similar for the other two drugs. Dr. Robert J. Spiegel, chief medical officer of Schering-Plough, said ''the prescription status of these medications is necessary to protect and optimize public health.''

Pfizer Inc., which makes Zyrtec, boycotted the meeting and refused to say why. ''We are exploring our options,'' a Pfizer spokeswoman said last night.

The issue has provoked a battle with few heroes, said Ira A. Loss, an analyst with Washington Analysis, which monitors federal agencies for investors. ''Wellpoint has a clear vested interest in getting the cost of the drugs off their books,'' he said. ''The drug companies are against it. And the doctors don't like the idea that the number of office visits might fall. It's hard to find an honest broker in the whole deal.''

Some panel members said that if approved for general sale, the drugs should carry warnings to elderly patients and parents of young children to consult a doctor about their use.

Critics of over-the-counter sales warned that symptoms associated with allergies might actually be asthma, a more serious condition that a doctor would recognize. But the manufacturers were unable to produce data showing that this confusion had caused widespread problems with the many nonprescription allergy drugs already in stores.

Some panel members contended that the F.D.A. should review and re-evaluate the existing nonprescription drugs. But the drug companies found it difficult to argue that their products were not safe, with or without a prescription. If the safety of any drug was in doubt, federal officials told the panel, its approval for sale would be swiftly revoked.

The manufacturers advertise that the three drugs are vastly superior to older remedies because they do not cause drowsiness. The companies spend millions of dollars each year to take their message directly to consumers. ''All that direct-to-consumer advertising came back to bite them,'' said Barbara A. Ryan, a health care securities analyst at Deutsche Bank.

Steve Francisco, a drug industry consultant, and editor of Switch, a newsletter, said Claritin accounted for 56 cents of Schering's earnings of $1.63 a share last year. ''If they were forced to switch, that would go to 6 cents and there would be a huge hit in the price of the stock,'' he said. ''It could result in a takeover.''

The current price of Claritin is about $2.13 a pill, or $192 for 90 pills, in the United States. In Canada, where it is already available over the counter, it can be purchased for about 70 cents a pill before taxes.

Shares of Schering-Plough rose $1.20, to $38.30, yesterday after Business Week said that Merck & Company was seeking a merger. Both companies declined to discuss the report.

But most analysts said they doubted the F.D.A. had the legal authority to force the companies to change the status of the drugs. They expect the companies to defend their products in court, and the cases could last for years until the drugs lose the patent protection that makes their high prices possible.

Stephen W. Schondelmeyer, an economist who specializes in pharmaceutical issues at the University of Minnesota, said: ''There are a lot of land mines in the politics of this. The law says the F.D.A. should give preference to making drugs over-the-counter products if they can be shown to be safe and appropriately used. But it has never been implemented that way. Selling over the counter has always been left to the discretion of the drug companies.''

Proponents of the change pointed to Canada, Germany, Britain and other countries where Claritin has been sold without prescriptions for more than a decade at much lower prices. ''Is the industry saying that American consumers are not as wise in using medicine as consumers in Canada or Mexico or England?'' Dr. Schondelmeyer asked.